|Publication number||US8092537 B2|
|Application number||US 12/592,698|
|Publication date||Jan 10, 2012|
|Filing date||Dec 1, 2009|
|Priority date||Feb 22, 2000|
|Also published as||CA2395393A1, DE60133370D1, DE60133370T2, EP1259198A2, EP1259198B1, US6984245, US7635371, US20030130737, US20050119753, US20060212120, US20100087875, US20120083890, WO2001062191A2, WO2001062191A3, WO2001062191B1|
|Publication number||12592698, 592698, US 8092537 B2, US 8092537B2, US-B2-8092537, US8092537 B2, US8092537B2|
|Inventors||Thomas V. McGahan, Steven D. DeRidder, Dayna Buskirk, Eric C. Lange|
|Original Assignee||Warsaw Orthopedic, Inc., Rti Biologics, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (41), Referenced by (8), Classifications (27), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present application is a divisional of U.S. patent application Ser. No. 11/437,392 filed May 19, 2006 now U.S. Pat. No. 7,635,371, a continuation of abandoned U.S. patent application Ser. No. 11/030,459 filed Jan. 5, 2005 entitled “Anterior Impacted Bone Graft and Driver Instruments”, which is a divisional of U.S. patent application Ser. No. 10/213,328 filed Aug. 6, 2002 entitled “Anterior Impacted Bone Graft and Driver Instruments” and issued as U.S. Pat. No. 6,984,245, which is a continuation of PCT Patent Application Serial No. PCT/US01/05638 filed Feb. 22, 2001 entitled “Anterior Impacted Bone Graft and Driver Instruments” which was published in English under Article 21(2) and which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/183,930 filed Feb. 22, 2000 entitled “Instruments and Implants for Multi-Directional Insertion of a Vertebral Spacer”. Each of the referenced applications is hereby incorporated by reference in its entirety.
The present invention relates generally to instruments and implants for intervertebral spacing. More specifically, the present invention provides instruments and implants that may be utilized to provide multi-directional insertion techniques to establish and maintain intervertebral spacing. Still more preferably, the present invention provides implants made of bone adapted to be inserted from more than one direction while maintaining proper orientation in the disc space.
The removal of damaged or diseased discs and restoration of disc space height to treat chronic back pain and other ailments, is well-known. Spacers are often utilized to maintain or reestablish disc space height after removal of all or a portion of the disc. Such spacing implants may include those promoting fusion between adjacent vertebral bodies, inert implants, and artificial disc implants. Such implants are typically designed to be inserted from an anterior, posterior or lateral approach. However, such implants are often designed for insertion only from one of the particular approaches to the spine. This is particularly true where implants are intended to maintain non-parallel angulation between adjacent vertebrae. Therefore, multiple implants each designed for insertion from one of the various approaches to the spine must be maintained in inventory to accommodate the various surgical demands of each procedure. Maintaining multiple implant designs may create inventory problems for both manufacturers and their customers. Moreover, the complications of creating multiple implants to accomplish the same desired spacing is compounded when implants are made of a scarce resources, such as allograft bone.
Therefore, there remains a need for instruments, techniques, and implants that reduce implant inventory without sacrificing desired implant configurations.
The present invention provides for instruments to implant a single implant design from multiple approaches to the disc space. In a preferred aspect of the present invention, instruments are provided for inserting an implant from a direct anterior approach to the spine and from an oblique-anterior approach to the spine.
In a further aspect of the present invention, an implant is provided that includes features permitting insertion into the disc space from multiple directions. In a preferred aspect of the present invention, the implant may be configured for insertion from a direct anterior approach as well as an anterior-lateral approach to the spine. Still more preferably, the anterior-lateral approach to the spine is from an oblique angle with respect to the sagittal plane.
In still a further aspect of the present invention, a multi-faceted implant is provided comprising an implant body having a first pair of substantially parallel side walls and a second pair of substantially parallel side walls. The second pair of substantially parallel side walls are disposed at an oblique angle with respect to the first pair of substantially parallel side walls. The angulation between the first and second set of parallel side walls permits insertion of the implant into the disc space from multiple directions. Further in one preferred embodiment the distance between the first pair of side walls is substantially identical to the distance between the second pair of side walls. One choice is to dispose the second pair of side walls at an angle of approximately 30 degrees with respect to the first pair of side walls. In a more preferred aspect of the present invention, the implant body has upper and lower bone engaging surfaces that are tapered to maintain angulation between adjacent vertebrae. In still further preferred aspects of the invention, one of each of the first and second pair of side walls includes an insertion tool bore.
In yet a further aspect of the present invention, a method of making an implant of boney material is provided. The method comprises forming a first pair of substantially parallel side walls on the boney material. A second pair of substantially parallel side walls is formed at an oblique angle with respect to the first pair of side walls. In one aspect the method further includes forming a plurality of driving surfaces on the donor bone. Still more preferably, the upper and lower bone engaging surfaces are disposed at an angle with respect to each other.
In still a further aspect of the invention an implant inserter is provided. Preferably, the implant inserter includes anti-rotation components to limit rotation of the implant about the longitudinal axis of the inserter and rotation about the axis of the implant itself In one preferred embodiment, the anti-rotation components comprise a pair of angled side walls on the inserter adapted to engage a pair of corresponding surfaces on the implant. In still a further preferred aspect, a threaded post engages a corresponding opening on the implant and the angled surfaces are spaced from the opening to limit stress placed on the implant adjacent the opening.
These and other objects of the present invention will become apparent from the following description of the preferred embodiments.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated devices, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
The present invention provides implants and instruments for multi-directional implantation of an intervertebral spacer. Additional instrumentation and techniques for disc space preparation are disclosed in Provisional Application entitled “Instruments and techniques for Disc Space Preparation,” filed Feb. 22, 2000. The disclosure of the referenced Provisional Application is incorporated herein by reference in its entirety. Referring now to
Implant 10 includes a pair of opposing side walls 24 and 26 formed in substantial parallel alignment with longitudinal axis 64. A further pair of oblique angled side walls 20 and opposing side wall 28 are formed at an angle A5 with respect to side walls 26 and 24. In a preferred embodiment, angle A5 is approximately 30 degrees. In a preferred aspect, from driving wall 18 extends substantially perpendicular to longitudinal axis 64 and at an angle of A4 with respect to angled surface 20. In a preferred embodiment, angle A4 is substantially 60 degrees. Implant 10 includes a front face 18 and an opposing end face 30. While not required, front face 18 and face 30 are planar surfaces in substantially parallel alignment. Further, front face 18 is substantially parallel to end face 30. A first opening 40 is formed in implant 10 and is internally threaded to receive an externally threaded post. Internally threaded opening 40 extends substantially along longitudinal axis 64 and in substantial alignment with side walls 24 and 26. A second bore 42 has an axis 66 extending substantially parallel to axis 64 and spaced at a distance D9 therefrom. Bore 42 is adapted to receive a substantially smooth pin. It will be understood that a pin extending in bore 42 will limit the tendency of implant 10 to rotate as an externally threaded rod is inserted into threaded opening 40. In a preferred aspect, distance D9 is approximately 5 mm.
Referring now to
Referring still further to
As shown most clearly in
Dimensions of donor bone vary depending on the source of the bone, as well as the specific location of the source of an allograft ring taken along a bone, such as the femur. In one aspect of the invention, intended for use in the lumbar spine, it is preferred that the implant have certain minimal dimensions for the safety and efficacy of the device. While such dimensions are disclosed herein, it is contemplated that dimensions may be altered for various implants in the lumbar, thorasic, and cervical spine without deviating from the present invention provided that the implant provides the desired strength and stability. Specifically, minimum dimensions are given from the surface of the outer side walls to central channel 16. As previously indicated, central channel 16 is preferably defined by the naturally occurring medullary canal. However, it may be altered or increased by additional machining to form a channel having desired dimensions or shapes. Side wall 19 has a dimension D5. Side wall 25 has a dimension D7. Side wall 31 has a dimension D4. Side wall 27 has a dimension D8. In a preferred aspect, dimensions D5, D7, and D8 are limited to a minimum thickness of 4 mm. Dimension D4 may have an even smaller minimum thickness of approximately 3 mm.
Referring now to
In a preferred embodiment, upper surface 12 includes buttressed ridges 13 providing an anti-migration surface to engage adjacent vertebral bone upon insertion and limit movement out of the disc space. In a similar fashion, lower bone engaging surface 14 includes a plurality of buttressed bone engaging ridges 15. Bone engaging ridges 15 are shown in greater detail in
The present invention further includes an implant inserter, such as that shown in
Distal guide 88 includes upper and lower tapered guiding surfaces 89 and 95, respectively. Guide 88 also includes substantially parallel opposed side walls 91 and 93. Guide 88 has a width W1 extending between side walls 91 and 93. Further, with reference to
Referring now to
In still another aspect of the invention, an oblique inserter is shown in
Referring now to
Referring now to
Referring now to
As with the implant according to the first embodiment shown in
The driving walls of implant 200 have been modified in comparison to the implant of
Referring now to
Referring now to drawing
Implant 200 may be inserted into a vertebral disc space properly prepared for receipt from a direct anterior approach. As shown in
Referring now to
Referring now to
Referring now to
While not shown by illustration, it will be understood that the implants described herein may be inserted from a direct lateral approach to the spine. The same orientation in the disc space may be achieved regardless of the direction of insertion and the guiding instruments used.
Thus, the present invention provides an implant having multiple facets or substantially parallel side walls allowing uniform orientation of the implant in the disc space although it is inserted by multiple, often guided, approaches to the spine. Specifically, the embodiments of the implants according to the present invention permit insertion from a direct anterior, oblique-anterior and a direct lateral approach to the spine. While preferred embodiments of the invention has disclosed three pair of substantially parallel side walls disposed at a various angles, it is contemplated that more than three pair of substantially parallel side walls could be utilized to provide for implant insertion from a plurality of angles. Further, while a particular angle of 30 degrees has been utilized for the purposes of illustration in a preferred embodiment, it will be understood that any oblique angle might be utilized to provide for insertion from multiple approaches from the spine.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.
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|International Classification||A61F2/28, A61F2/30, A61F2/46, A61F2/44, A61B17/56, A61F2/00|
|Cooperative Classification||A61F2310/00359, A61F2/4465, A61F2/4611, A61F2/442, A61F2002/2839, A61F2002/4475, A61F2002/30892, A61F2002/30879, A61F2002/4627, A61F2/28, A61F2310/00023, A61F2230/0069, A61F2310/00017, A61F2310/00179, A61F2002/30774, A61F2002/3023, A61F2002/30904, A61F2002/30787|
|European Classification||A61F2/44F4, A61F2/46B7|